Intravaginal optics targeting system

ABSTRACT

Intravaginal monitoring devices (IMDs) with adjustable optics assemblies support local and remote control of mechanical and electro-mechanical mechanisms associated with multiple imagers and other sensors for tailoring an IMD to meet the specific dimensions and characteristics of various female reproduce systems. Such mechanisms also assist in guiding and analyzing pathways through a vaginal channel to and including a cervix. Exemplary pivoting, rotational, and telescopic infrastructures with integrated, local and remote control and monitoring are supported with external visual displays of images and video streams in devices such as phones, tablet and laptop computers, and servers for use by a patient or any medical support staff. Such multiple images or video streams may be combined to provide an enhanced viewing experience.

CROSS REFERENCES TO RELATED APPLICATIONS

This application incorporates by reference herein in their entirety and makes reference to, claims priority to, and claims the benefit of:

a) U.S. Provisional Application Ser. No. 61/246,375 filed Sep. 28, 2009, entitled “Intravaginal Monitoring Device” by Ziarno et al.;

b) U.S. Provisional Application Ser. No. 61/246,405 filed Sep. 28, 2009, entitled “Network Supporting Intravaginal Monitoring Device, Method and Post Harvesting Processing of Intravaginally Processed Data” by Ziarno et al.;

c) U.S. Provisional Application Ser. No. 61/246,396 filed Sep. 28, 2009, entitled “Network Supporting Intravaginal Monitoring Device” by Ziarno et al.

d) U.S. Provisional Application Ser. No. 61/290,792 filed Dec. 30, 2009, entitled “Network Supporting Intravaginal Monitoring Device, Method and Post Harvesting Processing of Intravaginally Processed Data” by Ziarno et al.; and

e) U.S. Provisional Application Ser. No. 61/263,416 filed Nov. 23, 2009, entitled “Intravaginal Monitoring Architecture” by Ziarno et al.

Also incorporated herein by reference in their entirety are:

a) U.S. patent application Ser. No. ______ filed on even date herewith by Ziarno et al., entitled “Intravaginal Monitoring Device” client docket number PUS-L019-001;

b) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Network Supporting Intravaginal Monitoring Device” client docket number PUS-L019-002;

c) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Analysis Engine within a Network Supporting Intravaginal Monitoring” client docket number PUS-L019-003;

d) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Monitoring Support Architecture” client docket number PUS-L019-004;

e) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Therapy Device” client docket number PUS-L019-006;

f) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Dimensioning System” client docket number PUS-L019-007; and

g) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Optics Targeting System” client docket number PUS-L019-008; and

h) PCT patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Monitoring Device and Network” client docket number PWO-L019-001.

BACKGROUND

1. Technical Field

The invention generally relates to medical devices, and more particular to medical devices used in obstetrics and gynecology.

2. Related Art

The anatomical characteristics of a human reproductive system vary greatly from one woman to the next. For example, race, age, bladder condition, reproductive and surgical history, and current reproductive status, among many other factors, may affect sizes and orientations of underlying vaginal channels and cervical dimensions and orientations.

More particularly, across the spectrum of all women, anatomical characteristics of reproductive systems exhibit major variations in: (a) lengths between vaginal orifices to posterior fornices (˜60% variance); (b) lengths between vaginal orifices to anterior fornices (˜40% variance); (c) sizes of the introitus (˜70% variance); (d) straight line lengths between anterior to posterior fornices (˜70% variance); (e) straight line widths between lateral fornices (˜80% variance); and (f) vaginal orifice, mid vaginal and anterior fornix vaginal widths.

Similarly, as measured from the vaginal channel axis, cervical orientation exhibits substantial variation not only from woman to woman, but also within the same woman over time or depending upon circumstances. For example, significant variations across spectrum of women and within the same women occur due to the: (i) natural orientation of uterus; (b) vaginal channel alignment during later stages of pregnancy; (iii) reorientation with full/empty bladder; (vi) retraction during arousal; and (v) relocation post birthing with or without involvement of cesarean procedures.

In addition, vaginal channel does not usually run along a straight axis, but typically comprises one or more bends and associated curvatures between vaginal openings to the anterior fornix.

Cervical orientation also depends upon orientation of the uterus under the aforementioned situations. About eighty percent of women have a normal cervical orientation that varies throughout a 90 degree range, while tilted cervical orientations found in about twenty percent of women span about 45 degrees outside of the normal range.

Such large variations in female reproductive systems are also found in many other species beyond that of homo sapiens.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods of operation that are further described in the following Brief Description of the Drawings, the Detailed Description of the Invention, and the claims. Other features and advantages of the present invention will become apparent from the following detailed description of the invention made with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating intravaginal and cervical regions of a woman's body along with an intravaginal monitoring device (herein an “IMD”) to be inserted into place; wherein the intravaginal monitoring device is capable of guiding inside the optics cap to capture images of large portions of intravaginal and cervical regions that come in a wide ranging variation in dimensions;

FIG. 2 is a cross-sectional diagram illustrating various details and dimensional ranges underlying the reproductive system of the FIG. 1;

FIG. 3 is a further cross-sectional diagram illustrating other variants and angular frames of reference for the intravaginal and cervical regions of the female reproductive system of the FIG. 1 to be monitored by an IMD built in accordance with the present invention;

FIGS. 4 a through 4 h are schematic diagrams illustrating construction of one of the embodiments of the intravaginal monitoring device, along with typical dimensions, having manually adjustable optics encased with a (flexible) transparent optics cap;

FIGS. 5 a-c are cross-sectional diagrams illustrating a wide ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of FIG. 4 inserted therein, and wherein such IMD having multiple imager assemblies disposed within one type of transparent optics cap;

FIGS. 6 a-c are cross-sectional diagrams illustrating variations in dimensions, contours, and orientations of intravaginal and cervical regions, and, inserted therein, an IMD built in accordance with various aspects of the present invention such as having an adjustable optics assembly may be manipulated to better conform to such variations;

FIGS. 7 a-d are cross-sectional diagrams illustrating a wide ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of FIG. 4 inserted therein, and wherein such IMD having multiple imager assemblies disposed within yet other alternate shaped, transparent optics caps;

FIGS. 8 a-e are schematic diagrams illustrating construction of two embodiments of an intravaginal monitoring device along with typical dimensions, thereof, and having an actuator-controlled optical system and built in accordance with and to illustrate several aspects of the present invention;

FIGS. 9 a-f are diagrams illustrating construction of two embodiments of the intravaginal monitoring device along with typical dimensions, wherein such IMDs having mechanical and/or electro-mechanical structures supporting adjustable optics assemblies;

FIGS. 10 a-d are perspective diagrams illustrating further details regarding the adjustable optics assembly of FIGS. 9 a-b that supports two imager assemblies;

FIG. 11 is a perspective diagram illustrating an exemplary physical construction of an intravaginal monitoring device built in accordance with various aspects of the present invention to support manual optical system adjustment;

FIG. 12 is a schematic diagram illustrating internal circuitry involved in the construction of telescopic, actuator controlled, multi-directional front-end imager assembly guiding systems of various embodiments, of the FIGS. 4 through 9, of the intravaginal monitoring device;

FIG. 13 is a diagram illustrating a separate hand-held-device in communication with a dual imaging IMD with electro-mechanical image adjustment mechanisms built therein, and wherein two video sequences are simultaneously displayed to assist in both tailoring such IMD for use by a particular female, and assisting in insertion, framing, zooming, panning, and otherwise targeting of a cervical region within a vaginal channel;

FIG. 14 is a diagram illustrating a laptop computer, in communication with a dual imaging IMD with electro-mechanical image adjustment mechanisms built therein, wherein much like the hand-held device of FIG. 13, two video sequences are simultaneously displayed to assist in both tailoring such IMD for use by a particular female, and assisting in insertion, framing, zooming, panning, and otherwise targeting of a cervical region within a vaginal channel; and

FIG. 15 is a conceptual diagram illustrating visually a programmatic process of stitching the resulting images or video frames to obtain a wider angle view of the intravaginal and cervical regions, wherein such process may take place on an IMD or within any external, supporting device.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating a vaginal channel 113 and cervical regions 117, 121 of a woman's body along with an intravaginal monitoring device 191 to be inserted into place; wherein the intravaginal monitoring device 191 is capable of guiding inside the optics cap 171 to capture images of large portions of vaginal channel 113 and cervical regions 117, 121 that comprise a wide ranging variation in dimensions. The current illustration depicts an introitus 123 of a vaginal channel 113, cervix 121, outer surface 117 of the cervix 121, interior 119 of a uterus 107 in a normal orientation, fallopian tube 111, and ovary 109. Also, depicted is an exemplary overlay of a tilted uterus 115. As can be appreciated, the cervical orientation depends on, among other factors, the orientation of the uterus 107 (or uterus 115) under the various situations. Typical angular orientations in relation to the axial direction 195 of the vaginal channel 113 include normal orientations 151 and tilted orientations 153.

Wide ranging variations in the vaginal channel 113 and the cervical regions 117, 121 are important factors in design considerations of the Intravaginal Monitoring Device (IMD) 191. Considerations include, for example, focal lengths, fields of views, comfort and targeting with or without guidance assistance.

Multiple studies show that variations in the vaginal channel 113 and the cervical regions 117, 121 of a woman's reproductive system involve: (a) length between the introitus 113 and posterior fornix within the cervical regions 117, 121 (variations may range up to sixty one percent); (b) length between the introitus 113 and anterior fornix (may vary up to thirty seven percent); (c) size of the introitus (variations may be up to sixty seven percent); (d) straight line length between anterior to posterior fornices (may vary up to seventy two percent); (e) straight line widths between lateral fornices (variations may be up to sixty eight percent); and (f) widths and heights of the vaginal channel 113 (significant variations typically exist through the entire length). In addition, studies show significant variations across spectrum of women and within the same woman that occur due, for example, to: (a) natural orientation of uterus; (b) alignment of the vaginal channel 113 during stages of pregnancy; (c) reorientation with full or empty bladder; (d) retraction during arousal; and (e) relocation post birthing (especially evident after cesarean procedures).

In addition to the abovementioned factors, an intravaginal monitoring device 191 should also account for cervical orientation and insertion depth. Insertion depth of the intravaginal monitoring device 191 to the posterior fornix may not be easy across the spectrum of all women due to: (a) abnormal anatomical configurations; (b) cervical impact being misinterpreted as the posterior fornix; (c) anterior fornix being misinterpreted as the anterior fornix; or (d) insufficient nerve feedback of successful positioning. Moreover, for some women based on their current anatomical configurations, full insertion into the posterior fornix may not be optimal for capturing images and further information about the cervix or other areas within the vaginal channel 113. For a variety of reasons, including abnormal anatomical configurations and other reasons mentioned above, insertion by a particular woman over time (including monthly cycles or state of pregnancy) may involve insertion to differing depths.

The cervical orientation may be referred to as an angular measurement between the cervical plane & vaginal channel axis. For example, if a cervical plane is parallel to a vaginal axis, cervical orientation would be 0 degrees; a vaginal axis that is normal to a cervical plane would have a cervical orientation of 90 degrees. The cervical orientation exhibits substantial variation not only from woman to woman, but also within the same woman over time (for example, changes occur during pregnancy, based on bladder volume, in response to arousal, etc.). Vaginal axis is not usually a straight line, but typically comprises a bend or two and curvature between vaginal openings to the anterior fornix, complicating image capture.

In accordance with the present invention, the design considerations of the intravaginal monitoring device's 191 guiding procedures, and optics attempt to address all these variations. Such considerations are important whether the IMD comprises a “one size fits all” design or several independent designs (with each of the several designs being directed toward groups of women with relatively similar anatomical configurations).

Design considerations also take into consideration the woman's comfort involving characteristics such as stem flexibility, wear-ability, stem length, overall stem and cap widths and curvatures, and cap lengths and compressibility.

Although herein described with reference to human women, the various IMD embodiments within the present application are equally applicable to the reproductive systems of non-human female species. In particular, the IMD 191 employs a variety of techniques to address the wide variance in reproductive systems usable for all species.

In particular, with reference to the human female, the optics and guiding techniques of the IMD 191 address at least some of the anatomical variations of a female reproductive system. An optics assembly 177 may be adjusted to various positions within an inner cavity of a cap or optics cap 171. The optics assembly 177 includes two imager assemblies 173 and 175 to cover a wider field of view than would ordinarily be possible by using only a single imager assembly. The angle of the imager assembly 173 may also be manually or electro-mechanically adjusted. For comfort and to maintain rather optimal focal lengths, the optics cap 171 is relatively transparent, and can be made from a medical grade compressible polymer material, e.g., a soft silicone rubber. Most of these and other features and feature options not only accommodate reproductive system variations but also support comfortable, ease of use.

As previously mentioned, the optics assembly 177 may involve manual or electro-mechanical adjustment of both or either of the telescopic optics assembly and the angle of the imager assembly 173. The electro-mechanical approach involves, for example, the use of miniature piezo-electric actuators. Manual or electro-mechanical rotation of the optics assembly around the axis of the stem of the IMD 191 may also be employed to address a laterally oriented target such as a laterally situated cervix.

Control of the various actuators (controlling tilt, rotation and depth within the optics cap 171 can be controlled directly via an interface placed on the IMD 191, remotely by the user via a local computing device, and other computing devices remote from the user. Specifically, for example, such control might involve: (a) an dedicated hand-held device in local communication with the IMD 191; (b) a multipurpose device (such as a mobile phone, tablet computer or laptop computer) in local communication with the IMD 191; (c) a remotely located, dedicated or multipurpose device in communication with the IMD 191 via the Internet; (d) manual interaction via a user interface placed on the IMD 191 (e.g., a button); or (e) via twisting, turning, adjusting insertion depth, and otherwise manually manipulating the IMD 191 directly and without automation.

The imager assembly 175 is adjustable in a mostly radial direction 197, while imager assembly 173 is adjustable in a mostly axial direction 195. The images or video acquired from the imager assemblies 173, 175 may be displayed one at a time in a small or full screen window, or, if preferred, at the same time on a remote or local display. For example, upon insertion of the IMD 191 into the vaginal channel 113, a first image/video produced via the imager assembly 173 may be displayed (or primarily displayed) to support “gross” guidance of the IMD 191 into position. When in such gross position, a second image/video produced via the imager assembly 175 can be displayed (or become the primary display) to fine tune targeting of a radially located cervix. Primary display may involve replacing the first image/video with the second, but may also involve placing both image/video on the same display screen at the same time (perhaps even with an overlay scheme). Alternatively, in one particular configuration, the first and second image/video may also be stitched together to gain a wide angle image that covers more than 150 degree view of the outer surface of the cervix 117. Three dimensional imaging/video can also be constructed therefrom.

For instance, a woman who purchases and adjusts the optics assembly of an intravaginal monitoring device 191 to fit her present anatomy (possibly with the assistance of a health care professional) may continue to use the imager (with perhaps minor adjustment over the course of pregnancy) using guidance techniques provided by the IMD 191 and perhaps an external hand-held device. Adjustment is possible in the aforementioned ways, such as via the manually controlled or actuator controlled telescoping, rotation or angular adjustments of and within the optics assembly 177. Even the optics cap 171 can be replaced to adjust focal lengths or comfort as the area near the cervix 117 changes.

FIG. 2 is a cross-sectional diagram illustrating various details and dimensional ranges underlying the reproductive system of the FIG. 1. Specifically, the following description of the human reproductive system sets forth substantial variations in the dimensions found in female reproductive anatomy which the various aspects of the present invention attempt to accommodate.

For example, multiple studies show that variations of: (a) a posterior vaginal depth 211 between a vaginal orifices to a posterior fornix from 4.1 to 10.6 cm and average between 6.7 to 8.8 (depending on the study); (b) an anterior vaginal depth 213 between the vaginal oriface to an anterior fornix from 5.8 to 9.3 cm with an average of about 7.6 cm; (c) an introitus depth 217 from 1.5 to 4.6 cm with an average of 2.6 cm; (d) a cervix base length 215 that follows a straight line between the anterior and posterior fornices from 1.3 to 4.8 cm with an average of 2.9 cm; (e) a cervix base width (not shown) that follows a straight line between lateral fornices from 2.6 to 8.3 cm with an average of 4.2 cm; (f) a vaginal orifice width (not shown) from 1.9 to 3.7 cm with an average of 2.8 cm; (g) mid-vaginal channel width (not shown) from 1.6 to 3.7 cm with an average of 2.8 cm; and (h) anterior vaginal channel width (not shown) from 2.2 to 6.5 cm with an average of 3.3 cm.

To address at least some of these significant variations, one or more of the various adjustable characteristics, guidance techniques and comfort factors set forth in this application, can be combined with or incorporated into an intravaginal monitoring device in accordance with the present invention.

FIG. 3 is a further cross-sectional diagram illustrating other variants and angular frames of reference for the intravaginal and cervical regions of the female reproductive system of the FIG. 1 to be monitored by an IMD built in accordance with the present invention. The current depiction focuses on the wide ranging variation in the anterior fornix vaginal widths 395 that is to be taken into design considerations, since the wide angle image capturing depends upon these variations.

These variations of the anterior fornix vaginal widths can vary between 2.2 and 6.5 cm, with an average of 3.3 cm, as many studies show. Hence, there is a wide ranging variation between smallest 371 and largest 373 anterior fornix vaginal widths and the design considerations of the intravaginal monitoring device and its guiding process, in accordance with the present invention, encompass these important variations as well. In addition, the design considerations take into consideration the woman's comfort as well. A woman having a smaller anterior fornix vaginal width, as in the case of 371, may find it very uncomfortable to wear an intravaginal monitoring device of larger dimensions, designed with an average sized woman, as in the case of 379.

The depiction also shows: (a) Lengths between vaginal orifices to posterior fornix 311; (b) Lengths between vaginal orifices to anterior fornix 313; (c) Sizes of introitus 317; (d) Straight line lengths between anterior to posterior fornix 315; (e) Straight line widths between lateral fornix 315; (f) Vaginal orifice; (g) mid vaginal width; and (h) anterior fornix vaginal width.

The design considerations of the optics and guiding systems, in general, take into consideration these variations by ways of manually controlled or actuator controlled telescopic and stationary or actuator controlled rotating imager assembly of the imagers to focus upon specific regions of cervix and capture images. Hence, the variations that occur naturally in anatomy or due to circumstantial considerations, depth of insertion and variations of cervical orientation (based upon the range of 351, 353), from woman to woman and within a single woman over time are considerations for which many of the various aspects of the present invention are directed.

The depiction also shows angular measurements between the cervical plane & vaginal channel axis. For instance, if a cervical plane is parallel to a vaginal axis, cervical orientation would be 0 degrees; a vaginal axis that is normal to a cervical plane would have a cervical orientation of 90 degrees. Typically, studies show that eighty percentage of women have a normal cervical orientation (based upon the range of 353) that vary approximately between 0 degrees (as mentioned above) to 90 degrees (toward the backside, looking from the front); while twenty percentages of women have tilted cervical orientation (based upon the range of 351) that vary approximately between 0 degrees (as mentioned above) to 45 degrees (toward the front side, looking from the front).

The depiction also shows axial direction 377 and cervical angle 375 that are factors in designing the IMD and associated guidance process as well. The orientations of the axial and radial imager assemblies 173, 175 depend upon the cervical orientations or other intravaginal targets, which vary largely from woman to woman and within a single woman, during various circumstances.

FIGS. 4 a through 4 h are schematic diagrams illustrating construction of one of the embodiments of the intravaginal monitoring device, along with typical dimensions, having manually adjustable optics encased with a (flexible) transparent optics cap. The illustration of FIG. 4 g depicts an intravaginal monitoring device that consists of a dual segmented housing stem 431 (one which can be taken apart for storage within a small carrying case for example), and optics assemblies 429, optics cap 427 and bottom cap 433. The overall length of the IMD, the sum of dimensions 457 and 459, may vary depending on the inner electronics and batteries incorporated. In the illustrated embodiment, for example, the overall length may be 24 cm.

The FIGS. 4 a, 4 b, 4 c, 4 d, 4 e, 4 f and 4 h depict individual parts and steps of constructing an intravaginal monitoring device such as that of the FIG. 4 g. In particular, an optics assembly 429 (FIG. 4 g) consists of a telescopic stem 411 (FIG. 4 a) that has been cut to support a mounting arrangement as shown in FIG. 4 b (e.g., a telescopic stem portion 415 of a width 465 sized to fit within the housing stem 431). A platform portion 413 can be folded and manually adjust and readjusted, see folded platform 419 of FIG. 4 c, to support a desired radial mounting angle for an imager assembly 421 of FIG. 4 d. The axial mounting involves fixing an imager assembly 423 within a telescopic stem 425 as shown in FIG. 4 d. The optics system 429 can be adjusted by manually positioning the depth of the telescopic stem within the housing stem 431 and through clockwise or counterclockwise rotation.

In an alternate embodiment, the telescopic stem 428 can be extended and configured for rotation mechanically by a user via the end cap 433. Similarly, mechanical constructs (not shown) are contemplated to support pivoting of the axially mounted imager assembly. Such configurations would eliminate the need to remove the optics cap to gain access to and adjust the optics assembly orientation.

Among other details, the illustration also shows, an optics cap 435 depicted in the FIG. 4 e that is, in this embodiment, shaped irregularly with a bulge on one side so as to maximize focal length to the cervical area while taking advantage of natural elasticity associated with the region of the vaginal channel opposite the cervical surface. Typical dimensions 451 and 453 of the outer cap 435 can typically be 36 mm and 28 mm to serve a variety of types of women's reproductive systems and the specific underlying optics assembly requirements.

A battery compartment 499 contains batteries that are rechargeable or disposable. One or more buttons or other user input devices may be placed on the IMD. For example, a power button is illustrated as being located on the bottom of an end cap 495. The location of field of views 473, 475 of the axially and radially located imager assemblies are adjusted to minimize one imager assembly's image capture of the other to prevent having to crop or present a perhaps distracting element within each image/video stream captured.

Lastly, although only two imager assemblies are shown, many more are contemplated so as to provide full or partial 3D coverage of the vaginal space. Such multiple images and video streams can be presented independently or via a 3D merged image (video) viewing environment.

FIGS. 5 a and 5 b are schematic diagrams illustrating a wide ranging variation in dimensions of intravaginal and cervical regions and FIG. 5 c illustrating construction of the intravaginal monitoring device of FIG. 4, having a telescopic, actuator controlled, multi-directional front-end imager assembly guiding systems, having a (flexible) transparent optics cap that faces and fits snugly and flexibly onto the outer surface of the cervix. In specific, FIGS. 5 a, 5 b and 5 c depict the variations in the intravaginal and cervical regions, whereas some are larger in sizes, others are smaller, and some deviate from axial direction either way by smaller cervical angles or larger cervical angles.

FIGS. 5 a-c are cross-sectional diagrams illustrating a wide ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of FIG. 4 inserted therein, and wherein such IMD having a multiple imager assembly disposed within a further type of transparent optics cap. An axial imager assembly 509 covers an axial field of view 551. A radial imager assembly 513 covers a radial field of view 553. Both the radial and axial fields of view 551, 553 may be designed to cover, for example, a range of 90-100 or more degrees. Also, the label “radial” and “axial” as used above are not necessarily fully axial aligned, fully radially aligned, or have a 90 degrees angle of separation. In fact, as shown, the radial imager assembly 513 is about 30 degrees of the radial axis, while the axial imager assembly 509 is nearly in axial alignment but offset from the center of the axis of the telescopic stem. So as used herein, radial imagers are those comprising a location with a substantial radial component, while axially directed imagers comprise a substantial axial component.

Both of the axial field of view 551 and radial field of view 553 together cover about one hundred and fifty degrees, and with about forty degrees of overlap. Other configurations and embodiments with greater or lesser coverage and greater or lesser overlap is contemplated.

By using appropriate software in the IMD, a hand-held device, mobile device, personal digital assistant or computer, the a single “panoramic-like” image can be stitched and stretched together. Similarly, in the region of overlap, 3D images and video can be constructed from the two sources of image data (i.e., from the assemblies 513, 509). Alternatively, the axial field of view 551 and radial field of view 553 can also be viewed separately either by switching between each image/video stream or by simultaneously displaying both image/video streams.

FIGS. 5 b-c illustrate the vast differences in cervical sizes and orientations that will impact the performance of the IMD of FIG. 5 a. Although the positioning and repositioning process (e.g., via guidance supported procedures) may vary in difficulty, the illustrated IMD is able to capture adequate images for such variations.

FIGS. 6 a-c are cross-sectional diagrams illustrating variations in dimensions, contours, and orientations of intravaginal and cervical regions, and, inserted therein, an IMD built in accordance with various aspects of the present invention such as having an adjustable optics assembly may be manipulated to better conform to such variations. FIG. 6 a shows an exemplary insertion of an IMD through the vaginal channel and in an orientation that adequately captures images and video a cervix that falls within a field of view of a radial imager assembly 607. An axial imager assembly 611 captures only a portion of the cervical area but can be used: a) to assist in the guidance process by allowing the user to find and target the cervical area for image and video capture by the radial imager assembly 611; b) along with the image and video capture from the radial imager assembly 607 to construct a panorama, 3D imagery, etc.; and c) to support measurements of the cervical area such as the height of the cervix—an important indication during pregnancy.

The optics assembly of the IMD includes a stem 613, inserted within a main housing stem 614, that supports the imager assemblies 611, 607. An optics cap 609 may be made with a firm but compressible material (such as silicone rubber) that permits installation, removal and replacement. This may be accomplished by feeding the optics assembly into the inner chamber of the optics cap 609. Radial tension of the opening portion of the optics cap 609 due to elasticity of the optics cap 609 supports at least a partial hermetic seal and mechanical constraint.

The opening of the optics cap 609, although not shown, can be extended to mate with the housing stem 614 as an alternative to mating with the stem 613 (as shown). By mating with the housing stem 614, mechanical or electro-mechanical methods for extending the optics assembly further in or out of the inner area of the optics cap 609 might provide a more adequate seal, e.g., where the stem 613 is telescopic.

As illustrated, the field of view and underling mounting angle of the radial imager assembly 607 is adequately matched to the illustrated reproductive system's orientation and size. Exemplary fine tuning adjustment, however, might involve one or more of: a) installation of a different sized and shaped optics cap; b) relocating the radial imager 607 to provide better field of view coverage of the present cervix; c) changing the angle of the radial imager 607 to provide view more normal to the surface of plane of the cervix; d) extending or retracting the axial imager assembly 611 directly (or relatively via use of a longer cap) to (i) minimize having the radial imager assembly 607 within the field of view of the axial imager assembly 611, (ii) minimize having the axial imager assembly 611 within the field of view of the radial imager assembly 607, and (iii) attempting a better lateral image of the cervix by relocating the axial imager assembly 611. If selection of a different optics cap is not possible and the present optics cap is not sufficient, some of the adjustments identified above may be incapable of providing the best image and video capture, but may be the best compromise under the given reproductive system and IMD characteristics. Also note that larger optics caps may give rise to more difficult and uncomfortable insertion of an IMD. Thus, opting for a larger optics cap may not be a viable option.

FIG. 6 b demonstrates that with a slightly wider optics cap 610 replacing the optics cap 609 of FIG. 6 a along with repositioning of the angle of the radial imager assembly 607, better image and video capture of the exemplary cervix can be obtained. But note, however, that because the radial imager assembly 607 falls within the field of view of the axial imager assembly 611, the viewer of images and video captured by the axial imager assembly 611 will either have to be tolerated or the axial imager assembly 611 will also have to be moved. Although not shown, by moving the axial imager assembly 611 further into the cavity of the optics cap 610, the field of view impingement of the radial imager assembly 607 can be reduced, but at a cost to the capture by the axial imager assembly 611 of lateral cervical images and video. Such movement may also cause the axial imager assembly 611 to impinge on the field of view of the radial imager assembly 607. Although a yet larger optics cap might be used, it may very well be intolerable due to comfort and insertion constraints.

Also note that all movement and readjustments can be accomplished through direct manual interaction with the optics assemblies themselves, manual interaction with external mechanisms that cause mechanical readjustment of the optics assemblies, electro-mechanical interaction, or a combination of more than one of the above. This applies no matter how many imager assemblies are involved. Similarly, some portions of the optics assemblies may be fixed into stationary, non-adjustable arrangements, while other portions are fully adjustable. All such configurations are reasonable design choices for particular IMDs for certain targeted users and at various sales price points.

FIG. 6 c illustrates the insertion of an IMD much like that of FIG. 6 a within an entirely different vaginal channel and cervical orientation. Therein, it can be appreciated that a single imager assembly might be sufficient, as both of imager assemblies 627 and 631 are capable of capturing adequate images and video. Of course, by using dual imagers, 3D reconstruction or panoramic stretching and stitching might be used to provide a more rich viewing presentation. Adjustments to the position of the axial imager assembly 627 can be seen appreciated with reference to the “unadjusted” version within FIG. 6 a (i.e., the imager 607). Without such adjustment, the image and video captured by the imager assembly 627 would not span the cervical area.

FIGS. 7 c-d are schematic diagrams illustrating a wide ranging variation in dimensions of intravaginal and cervical regions and FIGS. 7 a and 7 b illustrating construction of the intravaginal monitoring device of FIG. 4, having a telescopic, actuator controlled, multi-directional front-end imager assembly guiding systems, having a (flexible) transparent optics cap that faces and fits snugly and flexibly onto the outer surface of the cervix.

FIGS. 7 a-d are cross-sectional diagrams illustrating a ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of FIG. 4 inserted therein, and wherein such IMD having a multiple imager assembly disposed within yet other alternate shaped, transparent optics caps. FIG. 7 a depicts the front-end portions of the intravaginal monitoring device inserted into place to capture images of a relatively small sized cervix. As depicted, it can be appreciated that a single imager assembly solution could be used (for example, by removing or disabling an axial imager assembly 713. With such removal, adjustments in a telescopic stem 715, via rotation or extension/retraction, and/or adjusting the location and angle of a radial imager assembly 711 could be made to “tune” the illustrated IMD to fit the current image and video capture environment.

In FIG. 7 b, an IMD much like that of FIG. 7 has received a different type of optics cap, an optics cap 729, than that found in FIG. 7 a (an optics cap 709). Such IMD is inserted within a differing shaped reproductive system. Instead of inserting the IMD until the optics cap 729 touches the cervical region, the insertion is stopped short thereof for possible capture of a larger region that includes the cervix. By doing so, the axial imager assembly 733 seems well capable of performing capture operations without the aid of the radial imager assembly 731. Thus, the radial imager assembly may be removed or turned off for such user.

FIG. 7 c illustrates a large tilted cervix wherein an IMD may itself be rotated (before or after insertion) or the underlying optics assembly may be rotated in accommodation of the tilt. Likewise, the relatively smaller cervix illustrated in FIG. 7 d may be services with a single imager assembly configuration and a much narrower and perhaps longer optics cap, and with or without the aforementioned accommodations for tilt. As mentioned previously, the process for selecting an initial IMD configuration—model and/or optics cap depends greatly on the features desired and the personal characteristics of the underlying female's reproductive system. The fitting process may be minimal if such reproductive system falls well within the ranges suggested by a particular IMD. When outside of such ranges, perhaps a different IMD and/or optics cap would be more appropriate. Such considerations may be addressed with professional selection and fittings (e.g., by an OBGYN), self exam, or trial and error.

FIGS. 8 a-e are schematic diagrams illustrating construction of two embodiments of an intravaginal monitoring device along with typical dimensions, thereof, and having controllable optical systems built therein accordance with and to illustrate several aspects of the present invention. In each embodiment, the intravaginal monitoring devices use electrically powered actuators (such as miniature piezo actuators) to support the tailoring of an IMD to attempt to comfortably conform to dimensions and orientations of a specific user's reproductive system. In the IMD of FIG. 8 a, in addition to electro-mechanical control, fully mechanical tailoring of some parts of the optical system is also shown.

In both of the IMDs of FIGS. 8 a and 8 b, the optics systems can not only be controlled prior to insertion, but also during the insertion process and when fully inserted. As mentioned before, such control and tailoring of the optics system to fit a current user is one purpose of the electro-mechanical and mechanical enhancements. Another is to provide a mechanism for panning, zooming, framing, and otherwise exploring a target area. All of these goals are easily accommodated with electro-mechanical and some mechanical adjustment mechanisms.

Specifically, in FIG. 8 a, a piezo actuator 813 controls the angle of a pivoting imager assembly 811. Beyond “tailoring,” such pivot control can also be used, for example, to assist in the guidance of an IMD 817 into position to target a cervix, and to pan, zoom, frame during insertion and at the insertion destination. All imager assemblies described throughout this application at a minimum contain an imager, such as, for example, CCD (Charge Coupled Device) or CMOS (Complementary Metal Oxide Semiconductor) varieties. Any other type of imager may be used which captures images and in some cases video are contemplated. In addition, such imagers need not operate in the visible optics range. For example, ultraviolet, infrared or other frequency electromagnetic wave imagers could be employed. Imager assemblies as described herein may also include one or more light (or other frequency) sources, a housing (supporting an optical pathway), lensing, aperatures, filters, polarizers, and auto-focus and auto-zoom mechanism. Other imager assemblies mentioned throughout the present application may be similarly constructed. Moreover, throughout this disclosure one or dual imager assemblies are used in each embodiment presented. Adding further imager assemblies, although not shown, is contemplated. All imagers underlying the imager assemblies herein are capable of capture still images (i.e., “snap shots”), video streams, or both.

A telescopic stem 815 may be manually adjusted to accommodate both an optimal radial angle in relation to a power button 819 (via depth adjustments via threading or tension), and the depth at which the optics assembly fits within an optics cap (shown in FIG. 8 c). It can also be adjusted through rotation of the telescopic stem 815 to accommodate off center or tilted image/video capture targets. The IMD also uses a flexible stem 817 (made of a for example silicone rubber) that contains the circuitry and power storage elements (e.g., batteries). A bottom cap 821 may also screw on or off to at least partially hermetically seal or expose or gain access to electrical or optical connectors, batteries, circuitry, etc. Although only a power button 819 is illustrated, a much more substantial user interface including a display is contemplated for some embodiments.

A typical example of a procedure for tailoring, guiding and targeting with the IMD of FIG. 8 a might first involve a doctor's measurement of a particular patient's reproductive system. Thereafter, with or without such information, the doctor or such patient might tailor (adjust) the optics assembly to fit the patient. That is, the doctor or patient may: a) manually adjust the depth of the telescopic stem 815 within the flexible stem 817; b) manually adjust (via optical assembly rotation) the pivoting plane with reference to the radial location of the power button 819; c) select and install a particular one of several sizes and shapes of optics caps (such as the optics cap 835 of FIG. 8 c); d) insert the device with guidance support via an externally viewable display; e) further adjust the angle of the imager assembly during insertion and upon after reaching the target insertion location; and f) remove and readjust the telescopic stem via rotation or insertion extent into the flexible stem 817 if necessary. The adjustment of the angle of the imager assembly 811 via the piezo actuator 813 may not only involve tailoring, but also supports dynamic viewing along with zoom, pan, and framing desires and capabilities of inherent in the imager assembly 811.

Guidance support might involve for example using the illustrated axial orientation of the imager assembly 811 during the insertion process to deliver a streaming video feed to an external viewing screen (not shown) through which guidance and initial positioning can be monitored. Through such screen, a user can determine when the target insertion location has been reached. They can also then control, via an external user input device, the piezo actuator 813 create a radial angle orientation to support image and video capture of a radially located cervix or artifact. Radial viewing might also be used during the insertion process to better examine vaginal channel walls prior to reaching the target insertion location.

In FIG. 8 b, similar operation can be found with the addition of further electro-mechanical elements that may support control before and after insertion and from external and remote devices. In addition to the electro-mechanical pivoting control of the IMD in FIG. 8 a, the IMD of FIG. 8 b is configured with automated telescoping and rotation. In particular, an imager assembly 823 is mounted such that a piezo actuator 825 can direct the imager assembly 823 through a wide range of radial angles such as that shown, and including a fully axial position (0 degrees as shown in FIG. 8 a). An actuator 826 is used to not only control the extension of a telescopic stem 827 into an optics cap, but also controls the rotational position of the pivot plane of the imager assembly 823 in relation to the power button 831.

Specifically, the base of the actuator 826 is inserted and affixed to the inner wall of a housing stem 829. The top end of a threaded (or ratcheted) post element of the actuator 826 connects to the telescopic stem 827 for raising, lowering, and seeking rotational alignment locations for the entire optical assembly.

With this configuration and whether or not fully or partially inserted, using an external display and user interface, the IMD of FIG. 8B can be fully adjusted to assist in insertion guidance, zooming, panning, framing, and tracking interesting intravaginal targets. Depending on the embodiments, a user interface interacting with the IMD's of FIGS. 8 a-b might only support direct and simplistic control commands such as clock-wise/counter clock-wise rotation, in-out telescoping, and up-down pivoting. Other embodiments also support actual angles of rotation and pivoting, and millimeter based telescoping positions with full “go to” functionality. Control may also involve any other three dimensional coordinate relocation as well, and, in any configuration, smooth or fixed movement increments at course and fine tuning speeds are employed. Moreover, the approaches to integrate electro-mechanical and mechanical adjustment techniques underlying the optics assemblies are merely exemplary as many other approaches and configurations are possible and contemplated.

Any IMD in accordance with aspects of the present invention can be built using various fully or partially automatic and/or manual techniques for best positioning elements thereof in any or all of three dimensions. As illustrated, such positioning elements comprise imager assembly and entire optics systems, but other IMD elements such as other sensors, emitters, drug or fluid delivery or fluid sampling systems that are integrated within an IMD may also benefit from the up to three dimensional mechanical or electro-mechanically driven repositioning systems shown throughout the figures. Thus, all positioning techniques described herein can be used along with guidance techniques and feedback from imagers or any IMD element to assist in its underlying function.

Manual control can be asserted directly by whomever inserts the IMD (depth, angles, torque, rotation, etc.) and by the woman's repositioning of her own body which also effects reproductive system dimensioning. Automatic positioning control over sensors such as an imager assembly, can be made via buttons placed on the IMD itself and monitoring of positioning feedback may be collected via a display disposed on the IMD housing. Positioning control may also be managed via a tethered or wireless link by a local computing device such as a cell phone, tablet computer or laptop. Remote positioning control may also be carried out via a longer distance link such as a wireless cellular network or Internet link to a remote computing device. The remote computing device may also be a phone, tablet computing device, server, or workstation computer through a doctor's or staffs interaction to analyze and diagnose a remotely inserted IMD.

Positioning of an optical assembly may also be used to assist in focusing, zooming or otherwise maintaining an adequate focal length to a target such as the cervix or opening of the cervical channel, or some other a gynecological event, artifact or condition. Positioning of other elements of an IMD to assist in their underlying functions is also contemplated as mentioned above for much of the same reasons. Such latter positioning may be carried out via integration with the former position mechanisms or via separate positioning constructs. For example, further sensors could be attached to a pivoting image assembly and benefit by sharing such pivot even though such sensors have alternate targets than the imager assembly and so the pivoting function could be time-shared. As an alternative, a separate pivoting platform under control via a further actuator would allow simultaneous operation although at the expense of extra materials and volume—which overall should be kept to a minimum for comfort, fitting and other reasons enumerated above.

In FIG. 8 c, among other details, the illustration shows a specific one of a plurality of types and sizes of optics caps, e.g., the optics cap 835. By being made of a somewhat flexible material such as medical grade, silicone rubber, the optics cap 835 may conform to sliding over optics assemblies while maintaining a hermetic seal with either or both of the telescopic stems 815, 827 or the housing stems 817, 829. Such hermetic seal may involve merely elastic tension associated with the diameters of the housing 817, 829 versus that of the optics cap 835. Such hermetic seal may be improved with a bonding agent or glue and/or a mechanical constraint such as ribbing or threading. End caps 821, 841 may similarly be attached using tension or with threading and/or other mechanical constraints (e.g., a grommet 839 of FIG. 8 e or glue) to at least provide partial hermetic sealing.

In one embodiment, the dimensions 851, 855, 857, 859, 861, 863 and 865 are such that the intravaginal monitoring device is able to accommodate the inner electronics appropriately, while attempting to support comfortable insertion, positioning, and maneuverability for a relatively large percentage of women. For example, the dimensions 851, 855, 857, 859, 861, 863 and 865 are approximately 235 mm, 16 mm, 25 mm, 16 mm, 35 mm, 15 mm and 10 mm respectively, though the dimensions may vary to accommodate other goals such as fitting within a small carrying case or purse, fully wearable versions, permanently tethered versions, versions supporting groups of females with different reproductive system profiles, to accommodate additional sensors or feature functionality, etc.

FIGS. 9 a-f are diagrams illustrating construction of two embodiments of the intravaginal monitoring device along with typical dimensions, wherein such IMDs having mechanical and/or electro-mechanical structures supporting adjustable optics assemblies. The embodiment of FIG. 9 a closely parallels that of FIG. 8 a and thus most of the description thereof applies equally to here. This applies to end cap 919, power button 917, housing stem 915 and most of the same adjustable optics mechanisms. For example, through manually rotating and adjusting the elevation of the stem 913 and electronic pivot control via a piezo-actuator 911, the illustrated IMD can be fitted to adequately match a variety of females. Post the beginning of the insertion process, the piezo-actuator can be controlled either internally, remotely or locally to assist in, for example, further insertion guidance, targeting and examination of a gynecological artifact, event or condition.

Similarly, FIG. 9 b is similar to the embodiment of FIG. 8 b, and as before can share most of the aforementioned detailed description regarding FIG. 8 b. For example, such details are applicable to power button 917, housing stem 929 and much of the same adjustable optics mechanisms. Through electro-mechanical adjustment via actuator 926, rotating and adjusting the elevation of the stem 927 along with electronic pivot control via a piezo-actuator 925, the illustrated IMD as before can also be fitted to adequately match a variety of females and further assist in the guidance, targeting, and examination within the vaginal channel.

A substantive difference between FIGS. 8 a-b and FIGS. 9 a-b, is that the latter includes a dual imager assembly arrangement—that is in addition to the imager assemblies 911, 923 imager assemblies 909, 921 can be found.

FIG. 9 c is an exemplary symmetric optics cap which is merely one of many types and sizes available to help tailor the IMD to the particular patient. FIG. 9 d illustrates an inner cap 933 that is relatively harder plastic that can be used with the IMD of FIG. 9 b for example to cover and hermetically sealed the optics assembly. When the inner cap 933 is used, an outer cap such as the outer cap 935 of FIG. 9 c provides a secondary covering by sliding it over the inner cap 933. In this way, the flexibility of the outer cap 935 will provide comfort and adequately expand the intravaginal areas to be imaged.

In general, the dimensions 951, 953, 955, 957, 959, 961, 963, 991, 993, 995 and 965 are such that the intravaginal monitoring device is able to accommodate the inner electronics appropriately, and at the same time a woman is able to insert and maneuver it in place (as well as with considerations of comfortable wear for the woman). In a specific embodiment, dimensions are nearly the same as that set forth in relation to FIGS. 8 a-e above.

FIGS. 10 a-d are perspective diagrams illustrating further details regarding the adjustable optics assembly of FIGS. 9 a-b that supports two imager assemblies. Space is at a premium within optics caps. Initially, such cap sizes take into account the need function of spreading the tissues in the target insertion zone so that adequate illumination and image capture can take place. Small form factor on the other hand is a desire for insertion comfort reasons. An optics cap length can also be shortened or lengthened to accommodate targets such as the cervix which may be axially located very close to the vaginal oriface or, alternatively, at the back of the vaginal channel. Overall cap size must also take into account focal lengths, imager and mounting assembly sizes, etc.

In FIG. 10 a, a standard, side-by-side arrangement of two imager assemblies 1013 and 1015 is shown. Through manual or electro-mechanical control, a stem 1017 can be rotated and elevated, and a mounting platform 1011 can be pivoted.

FIG. 10 b illustrates that a rivet 1020 or other tension based interconnect between imager assemblies 1019, 1021 may further permit an angular adjustment between the two imager assemblies 1019, 1021. To save space yet sacrifice such angular adjustment, FIG. 10 c illustrates overlapping cavities of imager assemblies 1023, 1025 to a level that does not cause interference with each optical path. Fully overlapping cavities are also possible yet not shown. In FIG. 10 d, although imager assemblies 1027, 1029 appear to be connected, they are merely co-located with separate mounting platforms and corresponding separate actuators to provide separate pivot control for each.

FIG. 11 is a perspective diagram illustrating an exemplary physical construction of an intravaginal monitoring device built in accordance with various aspects of the present invention to support manual optical system adjustment. The illustration depicts an axial imager assemblies 1111 and a radial imager assembly 1115 disposed on a mounting bracket 1117. The mounting bracket 1117 may be metallic or otherwise made to conform under normal finger pressures to various positions. Specifically, platform 1113, of the mounting bracket 1117, supports the radial imager assembly 1115. The platform 1113 may be bent to conform to optics demands required by a particular user. Likewise, a platform 1116 portion of the mounting bracket 1117 can be bent to readjust the angle of the axial imager 1111, if need arises. The mounting bracket is inserted via a screw cap 1119 and into a telescopic stem 1121 that is also capable of rotation. Glue can be added to hermetically adhere the portion of the mounting bracket 1117 spanning inside the stem 1121. By inserting the telescopic stem 1121 through the bottom of a housing stem 1127 (only an upper portion of which is shown), a flange within the housing stem 1127 (not shown) and corresponding lip 1123 prevent the telescopic stem 1121 from falling out of the housing stem 1127 in the upward direction. By first adjusting the depth and rotation angle of the telescopic stem 1121 and then tightening the screw cap 1119, the optics assembly can be adjusted and secured for further use.

FIG. 12 is a schematic diagram illustrating exemplary internal circuitry utilizing electro-mechanically controlled optics elements, which may be employed in whole or in part within the various IMDs illustrated in the various figures of the present application. Electronic circuitry and components shown are typically located within a hermetically sealed portion of an intravaginal monitoring device. Such electronics are mostly located within a housing stem of an IMD, but specific components or particular portions of the circuitry may be located elsewhere, e.g., within an optics cap, an end cap, or in a device remote from the IMD itself.

The electronics include sensors such as image capture assemblies 1207 that deliver still images (i.e., “snap shots”) and streamed video, and that may comprise for example an axial imager (or imager assembly) 1209, a radial imager (or imager assembly) 1211, distance sensor 1221 (which may comprise for example an axial laser diode pair 1223 and a radial laser diode pair 1225. Other sensors and components may be added, such as a thermometer 1231 or a microphone 1233. Other components include a power button 1235, USB circuitry 1241, Bluetooth® communication circuitry 1243, and flash memory 1255. Positional control circuitry & electro-mechanical components 1245 enable an interface and control circuitry 1257 used to fully or partially adjust the up to three dimensional positioning of any sensor or optical element within the IMD. A power regulation circuitry 1263 manages power delivery from a battery pack 1265, and, if so configured, supports recharging thereof via external power. The battery pack 1265 may be rechargeable or disposable.

The interface and control circuitry 1257 also manages and controls all of the components and circuitry by using either internal preprogrammed firmware, a loaded software application, or a combination of both. Such program code can be replaced by using well known schemes such as local downloading, flash memory installation, over the Internet or over the air updates, etc.

The interface and control circuitry 1257 can also be directed, in part, remotely, via the Bluetooth® or USB communication circuitry 1243 and 1241 via wireless or wired links, respectively. Such links could support communication through which data (images, video, sensor information, etc.) and commands could be sent or received. The recipient or sender of such communications could be, for example, (a) a dedicated device designed for use with IMDs (e.g., a hand-held device with a display and user interface); (b) a general purpose device running an application designed for use with the IMD (e.g., a smart phone, tablet computer, laptop computer, etc.); or (c) a server or stand-alone computing system running an application designed for use with IMDs. In any of the above examples, such devices can be local to the IMD and used by the person managing the local insertion and data collection using an IMD (e.g., the patient, doctor or assistant). Likewise the examples could involve remotely located devices reachable via wireless cellular and/or Internet connectivity.

As mentioned previously, electro-mechanical control can be carried out using one or more servo actuators, such as the ones available from various companies such as Alps Electric Co, Ltd.®. Such actuators may control, for example, telescopic, rotational, pivoting or other motion of an optics element or assembly (e.g., imager assemblies 1209 and 1211) and any other sensor or element within the IMD. The positional control circuitry 1245, in response to directions received from the interface & control circuitry 1257, controls an electro-mechanical actuator, for example, to rotate an optics assembly, at a fixed rate, in clockwise or counterclockwise directions. The circuitry 1245 may also controls other actuators to cause elevation of a telescopic stem portion of an optics assembly. Other types of actuator configurations and resultant movements of any element within the IMD is also contemplated.

FIG. 13 is a diagram illustrating a separate hand-held-device, in communication with a dual imaging IMD with electro-mechanical image adjustment mechanisms built therein, wherein two video sequences are simultaneously displayed to assist in both tailoring such IMD for use by a particular female, and assisting in insertion, framing, zooming, panning, and otherwise targeting of a cervical region within a vaginal channel. The hand-held device is communicatively coupled to an IMD (not shown) to receive images and video streams and to exchange control signals. As illustrated, the hand-held device is receiving and displaying a first video stream from an axial imager assembly of the IMD within a window 1353. Simultaneously, the hand-held device receives and displays in a sub-window 1351 a second video stream that originates from a radial imager assembly within the IMD. The video being displayed within the window 1353 can be swapped with that being displayed in the sub-window 1351 by the user as desired. Both steams can be delivered in a wired or wireless manner and via any or no communication node intermediaries (that is, via either point to point or routed pathways). Such communicative may involve any of a large number wired or wireless interfaces such as USB, Bluetooth®, infrared, and WiFi.

Repositioning of various optical systems or elements thereof can be controlled via a user interface associated with the hand-held device. For example, zooming, panning, focusing pivoting, etc., can be directed through button input or through other interface techniques such as finger pinching, double finger twisting, and finger sliding motions while in contact with a touch sensitive screen infrastructure. Guidance during insertion and positioning of the IMD can be more easily achieved and confirmed by observing one or both of the screens 1353 and 1351, during such processes. All other types of control and adjustments mentioned throughout this specification are also possible via the illustrated device.

In addition, the hand-held device also contains a plurality of buttons, such as record button 1311, IMD power button 1313, volume button 1315, snapshot button 1317 and IMD status button 1321. The record button 1311 allows continuous local and remote storage of the video streams being received and displayed in the windows 1353, 1351. Recorded video need not be of the same resolution of that being displayed. This can be accomplished through interaction with the IMD or via transcoding within the hand-held device. Similarly, the snapshot button 1317 triggers an image capture command's delivery to the imager assemblies within the IMD. In response, captured images (with perhaps differing resolution of that of the video stream) are delivered via the communication link and can be displayed via the windows 1353, 1351 and remotely and locally stored. Alternatively, images could be reconstructed from the ongoing video stream, if resolution an adequate quality is present.

The hand-held device may also contain a plurality of light status indicators 1355 (which could be other types of indicators or display elements) that indicate power status, communication link status, snapshot and recording indications, and so forth.

Configuring other aspects of the IMD and the present hand-held device may be made via software instructions underlying the setup button 1321. To check on the overall status of the IMD, software underlying the IMD status button 1321 will trigger a communication exchange of status information such as operational condition, storage usage, ownership information, etc. The IMD power button 1313 may also assist by triggering or otherwise displaying the remaining power and usage characteristics of the associated IMD.

FIG. 14 is a diagram illustrating a laptop computer, in communication with a dual imaging IMD with electro-mechanical image adjustment mechanisms built therein, wherein much like the hand-held device of FIG. 13, two video sequences are simultaneously displayed to assist in both tailoring such IMD for use by a particular female, and assisting in insertion, framing, zooming, panning, and otherwise targeting of a cervical region within a vaginal channel. All of the description provided with respect to FIG. 13 applies equally to the laptop computer 1417 illustrated in FIG. 14. The only exception perhaps is that a patient conducting the IMD insertion and monitoring process may find that interacting with the hand-held device somewhat easier to manage. This distinction may apply equally to anyone that desires to perform the insertion while reviewing video or image feeds.

For example, the communicative coupling between an intravaginal monitoring device and the laptop computer 1417 may be accomplished via any point to point or routed communication infrastructure, e.g., wired or wireless interfaces such as USB, Bluetooth®, infrared or WiFi and through the Internet or cellular network infrastructures. The laptop computer 1417 may be located in the same room as the patient and IMD, yet may alternatively be located remotely.

Instead of one main window and one sub-window (or frame), the much larger screen 1415 of the laptop computer 1417 versus that of the hand-held device (FIG. 13) permits the presentation of two reasonably large sized “split-screen” windows 1411, 1413 of image and video feeds received from the IMD as they are captured.

Once communicatively coupled to the IMD, the laptop computer 1417 provides two images or video streams (e.g., a first from an axial imager and a second from a radial imager). The video streams or images are then presented in the two windows 1411 and 1413 which can be resized, stretched or overlapped in typical fashion.

The laptop computer 1417 operates pursuant to a program application designed for use with the IMD. In addition to directing the management of the screens 1411, 1413 and user input devices (keypad or pad), the program application provides control signals to manipulate the electro-mechanical components within the IMD as discussed throughout this application.

FIG. 15 is a conceptual diagram illustrating visually a programmatic process of stitching the resulting images or video frames to obtain a wider angle view of the intravaginal and cervical regions, wherein such process may take place on an IMD or within any external, supporting device. Particularly, stitching software receives two simultaneously captured images (or video frames) 1511, 1513 (perhaps one axially and one radially collected) from the IMD. The stitching software uses correlation techniques and known positional information regard the underlying imager locations and cervical distances to create (via stretching, stitching, and combining) a single two dimensional image by combining the received image data. This process is roughly illustrated via a single screen 1515 through which the images are modified and merged.

Although the various aspects of the present invention have been described in relation to the human species, similar constructs of IMDs of perhaps differing sizes and shapes are contemplated employing such various aspects of the present invention to support monitoring of female reproductive systems of other species.

The terms “circuit” and “circuitry” as used herein may refer to an independent circuit or to a portion of a multi-functional circuit that performs multiple underlying functions. For example, depending on the embodiment, processing circuitry may be implemented as a single chip processor or as a plurality of processing chips. Likewise, a first circuit and a second circuit may be combined in one embodiment into a single circuit or, in another embodiment, operate independently perhaps in separate chips. The term “chip”, as used herein, refers to an integrated circuit. Circuits and circuitry may comprise general or specific purpose hardware, or may comprise such hardware and associated software such as firmware or object code.

As one of ordinary skill in the art will appreciate, the terms “operably coupled” and “communicatively coupled,” as may be used herein, include direct coupling and indirect coupling via another component, element, circuit, or module where, for indirect coupling, the intervening component, element, circuit, or module does not modify the information of a signal but may adjust its current level, voltage level, and/or power level. As one of ordinary skill in the art will also appreciate, inferred coupling (i.e., where one element is coupled to another element by inference) includes direct and indirect coupling between two elements in the same manner as “operably coupled” and “communicatively coupled.”

The present invention has also been described above with the aid of method steps illustrating the performance of specified functions and relationships thereof. The boundaries and sequence of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternate boundaries and sequences can be defined so long as the specified functions and relationships are appropriately performed. Any such alternate boundaries or sequences are thus within the scope and spirit of the claimed invention.

The present invention has been described above with the aid of functional building blocks illustrating the performance of certain significant functions. The boundaries of these functional building blocks have been arbitrarily defined for convenience of description. Alternate boundaries could be defined as long as the certain significant functions are appropriately performed. Similarly, flow diagram blocks may also have been arbitrarily defined herein to illustrate certain significant functionality. To the extent used, the flow diagram block boundaries and sequence could have been defined otherwise and still perform the certain significant functionality. Such alternate definitions of both functional building blocks and flow diagram blocks and sequences are thus within the scope and spirit of the claimed invention.

One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.

Moreover, although described in detail for purposes of clarity and understanding by way of the aforementioned embodiments, the present invention is not limited to such embodiments. It will be obvious to one of average skill in the art that various changes and modifications may be practiced within the spirit and scope of the invention, as limited only by the scope of the appended claims. 

1. A monitoring device sized for at least partial insertion into a plurality of vaginal channels, each of the plurality of vaginal channels having a corresponding one of a plurality of cervixes disposed therein at different locations and orientations, the monitoring device comprising: a first imager that captures data in a first field of view; a second imager, disposed in an adjustable configuration, that captures data within a second field of view; the first imager being disposed in a more axial orientation than that of the second imager; and adjustments made to the adjustable configuration of the second imager assist in placing the second field of view to at least partially contain a first cervix of the plurality of cervixes within a first vaginal channel of the plurality of vaginal channels.
 2. The monitoring device of claim 1, further comprising an electro-mechanical component that manipulates the adjustable configuration of the second imager.
 3. The monitoring device of claim 1, further comprising a mechanical structure supporting manual interaction to manipulate the adjustable configuration of the second imager.
 4. The monitoring device of claim 2, further comprising communication circuitry through which control signals are received, the control signals directing the electro-mechanical component in performing the manipulation of the adjustable configuration.
 5. The monitoring device of claim 1, further comprising communication circuitry through which the data captured by the second imager from the second field of view is delivered.
 6. The monitoring device of claim 5, further comprising an electro-mechanical component that responds to control signals to change the adjustable configuration of the second imager, and the delivery through the communication circuitry of the data captured by the second imager from the second field of view supports generation of the control signals.
 7. The monitoring device of claim 1, wherein the data captured in the first field of view by the first imager comprising video data.
 8. The monitoring device of claim 1, wherein the data captured in the first field of view by the first imager comprising still image data.
 9. A monitoring device sized for at least partial insertion into a plurality of vaginal channels, a first vaginal channel of the plurality of vaginal channels having there within a first intravaginal target, the monitoring device comprising: an imager, disposed at an adjustable angle, that captures data within a field of view; an electro-mechanical component disposed to change the adjustable angle of the imager; and circuitry that directs the electro-mechanical component to assist in at least partially encompassing within the field of view the first intravaginal target of the first vaginal channel.
 10. The monitoring device of claim 9, further comprising: control circuitry coupled to the electro-mechanical component; communication circuitry, coupled to the control circuitry, through which control signals are received and forwarded to the control circuitry; and the control circuitry responding to the control signals by directing the electro-mechanical component in making the change to the adjustable angle of the imager.
 11. The monitoring device of claim 9, further comprising communication circuitry, and the captured data is communicated outside of the monitoring device via the communication circuitry.
 12. The monitoring device of claim 10, wherein the captured data is communicated outside of the monitoring device via the communication circuitry to support generation of the control signals.
 13. The monitoring device of claim 11, wherein a computing device outside of the monitoring device receives and displays the captured data.
 14. A method used to capture data within a vaginal channel, the method comprising: inserting an imager at an orientation angle into the vaginal channel; adjusting the orientation angle of the imager via electronic signaling that originates outside of the vaginal channel; and forwarding data captured by the imager within the vaginal channel to a location outside of the vaginal channel.
 15. The method of claim 14, wherein the adjustments of the orientation angle and forwarding of data occur within a first device housing, and further comprising: receiving the forward data within a second device housing; displaying the received data; and generating the electronic signaling from within the second device housing.
 16. The method of claim 14, wherein the forwarded data is routed through a communication network.
 17. The method of claim 14 performed within a first device housing, and wherein the forwarded data is received within a second device housing.
 18. The method of claim 17, wherein the second device housing comprising a hand-held device housing.
 19. The method of claim 17, wherein the second device housing comprising a computing device housing, and the forwarding comprises routing through a communication network.
 20. The method of claim 17, wherein the vaginal channel and the first device housing are located at a first premises, and the second device housing is located at a second premises. 